Vor Bio licensee RemeGen has reported a positive Phase III readout regarding its drug telitacicept as a treatment for Sjögren's syndrome.

In the late-stage trial (NCT05673993) in China, the fusion protein met its primary endpoint, improving EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) scores significantly during 24 weeks. It also exhibited a favourable safety profile.

Though RemeGen has not yet disclosed the fine details of the study’s outcomes, Vor Bio noted that the results of this trial position telitacicept as a potential best-in-disease treatment, with its CEO and chair Jean-Paul Kress stating that the drug could “set a new benchmark in the field”.

RemeGen will disclose further details on the study at various upcoming international academic conferences, and the Phase III data will be used to file for approval of the drug in Sjögren's syndrome with China’s Center for Drug Evaluation.

The drug, marketed as Taiai, has already been approved in China to treat myasthenia gravis (MG), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).

Outside of China, RemeGen has also obtained FDA clearance for a US-based Phase III trial of telitacicept in patients with Sjögren's syndrome, with Vor Bio currently evaluating the timing of the Phase III clinical study in Sjögren's Syndrome. The drug received Fast Track designation from the US Food and Drug Administration (FDA) in April 2024.

PureTech Health subsidiary, Vor Bio, purchased the exclusive rights outside of the ex-Greater China region to the fusion protein in June 2025 for a $125m upfront payment. The company has also vouched to hand over more than $4bn in potential regulatory and commercial milestone payments moving forward.

Rapid progress in Sjögren's syndrome

This is the third positive trial readout in Sjögren's syndrome this week, with Novartis’ monoclonal antibody (mAb) ianalumab meeting its primary endpoints in two Phase III trials. If approved, ianalumab and telitacicept would be the first targeted therapies to gain approval in this indication in the US.

If approved, these drugs are forecasted to be neck and neck in terms of sales, with telitacicept and ianalumab expected to make $582m and $638m, respectively, by 2031, according to GlobalData analysts.

GlobalData is the parent company of Clinical Trials Arena.

The only other looming competition for telitacicept is Argenx’s neonatal Fc receptor (FcRn) blocker, Vyvgart (efgartigimod alfa + hyaluronidase), which is currently in late-stage trials for Sjögren's – with a top-line readout expected in 2027.

The immunoglobulin G (IgG) Fc-antibody fragment, which is approved for chronic inflammatory demyelinating polyneuropathy (CIDP) in the US, pulled in sales of $949m in Q2 of 2025, according to a statement from Aregenx on 31 July.